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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic HeartWare HVAD System

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  Class 1 Device Recall Medtronic HeartWare HVAD System see related information
Date Initiated by Firm May 02, 2018
Date Posted May 21, 2018
Recall Status1 Open3, Classified
Recall Number Z-1903-2018
Recall Event ID 80056
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product Heartware Medtronic HVAD System for cardiac use. Including the following parts:
(a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420
(b) DC Adapter, Product numbers: 1435, 1440
(c) AC Adapter, Product numbers: 1425, 1430
(d) Battery Pack, Product number: 1650DE


Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.
Code Information ALL SERIAL NUMBERS  UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement  1403: 00888707000116, 00888707000475  1407: '00888707000291, '00888707000727, '00888707000710,   00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472  1420: '00888707000420, '00888707000437, '00888707002660  (b) 1435: '00888707000109  1440: '00888707000260, '00888707001885, '00888707001496,  '00888707002745  (c) 1425: '00888707000093  1430: '00888707000307, '00888707000826, '00888707000833,  '00888707000840, '00888707000857, '00888707000871, '00888707000864,  '00888707000888, '00888707000901, '00888707000505, '00888707000895,  '00888707000918, '00888707001489, '00888707001779, '00888707001786,  '00888707001793, '00888707001809, '00888707001816, '00888707001823,  '00888707001830, '00888707001847, '00888707001854, '00888707001861,  '00888707001878, '00888707002738, '00888707002769, '00888707002776,  '00888707002783, '00888707002790, '00888707002806, '00888707004817  (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653,  '00888707000376     
Recalling Firm/
Manufacturer		 Heartware
14400 NW 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact
877-367-4823
Manufacturer Reason
for Recall		 Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.
FDA Determined
Cause 2		 Device Design
Action The firm notified physicians and healthcare professionals about the device correction by letter on 05/02/2018. The letter explained problem and provided recommendations for effective power source management of the system. Medtronic began notifying VAD Clinicians in the US on May 31, 2018, mainly via 2-day courier, and OUS via locally approved methods, of a newly available field service. A field service for application of a lubricant to the HVAD System power source connectors to mitigate the potential for transient interruptions of the electrical connection between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the HVAD Controller is now available.
Quantity in Commerce 175878 devices
Distribution Worldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, , Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic
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